The new Europe In Vitro Diagnostic Medical Device Regulation (IVDR) is on the horizon. While the 2022 deadline may seem distant, manufacturers need to start taking steps now to achieve compliance. The increased number of modifications, definitions, classifications, and conformity assessments will involve careful evaluation and process revisions. Significant requirements for clinical evidence will also be enforced, with an increased focus on intended use and user environment. Most notably, individual trials for each unique product will be required, with a user environment relative to laboratory, near-patient testing (NPT) and self-testing.
Key Dates to Remember:
May 26th 2022 – EUDAMED will go live.
May 26th 2022 – IVDR date of application.
May 26th 2024 – AIMD, MDD and IVDD certificates become void; after this date devices will no longer be approved for the EU market under these certificates.
May 26th 2025 – Devices can no longer be put into service in the EU using AIMD, MDD or IVDD certificates.
Prepare and Budget for Your Project
Contact us today and an expert will be in touch to help you determine your specific project needs.
Plan Your Path to Compliance
Prepare your organization before you take official steps.
Have an expert review your current Quality Management System (QMS) to identify anything missing that would prevent your compliance with IVDR.
Engage consultants to amend and implement changes to your QMS and provide all necessary documentation.
Implement a training program to inform all team members about IVDR-related changes that have been made to your production process.
Get an IVDR expert to conduct a mock inspection to see if they can find any instances of IVDR noncompliance in your facility.
Conduct tests to verify that your IVDR-compliant process works flawlessly in every situation.
6 Official Steps to IVDR Compliance
Pass a conformity assessment
(this does not apply to most Class A IVD medical devices)
Draft a Declaration of Conformity
Place a CE mark on the device
Assign a Basic UDI-DI and provide it to the UDI database
Submit key manufacturer and authorized representative information (and if applicable, importer) to EUDAMED
Place your CE marked device into the European market
First Things First
Get started now to stay on track.
Our detailed infographic outlines the steps you need to take to achieve IVDR compliance.
If you have limited internal resources or need help developing your strategy, Oxford can provide you with experienced consultants and planning support. Our flexible staffing and consulting services are tailored to fit your needs and can support a range of projects including:
Conducting a review of manufacturer requirements
Performing a gap assessment against your existing Quality Management System (QMS)
Amending and implementing your QMS
Applying an amended QMS to your product portfolio
Learn how a large pharmaceutical organization was able to achieve compliance and deliver 50 new combination products to market.
Tap Into Our Network of Talent
With our global network of consultants, we can help you find the right individual talent, or help you build your own custom project team. Many of our IVDR compliance experts have held senior positions with leading IVD manufacturers; their experience and knowledge enables us to offer best-in-class IVDR expertise.